How do you know if the drug you’re on works? You don’t

One of the comforting myths about the powerful drugs used in modern medicine is that they are prescribed on the basis of good scientific evidence. However this is an illusion, which experts have known about for decades, because drug companies can prevent doctors and regulators from seeing unfavourable evidence. If you are being prescribed a drug, the evidence for its effectiveness and safety may be more like advertising than reliable scientific data.

This is the topic of a new post on the blog I edit at HealthInsightUK.org. We are writing about it because there is now a serious campaign to deal with this fatal flaw in the assumption, constantly repeated by medical professionals, that they practice evidence based medicine. It’s a claim that should be regarded as holed below the waterline.

This is not just me as a slightly maverick journalist talking. The size of the problem comes out very clearly in the latest report by the doughty Commons Public Accounts Committee which looked into the saga of Tamiflu – the flu drug which we taxpayers have spent nearly £500 million on without anybody having any real evidence that it was safe or effective.

In fact in her evidence to the committee the editor of the BMJ (British Medical Journal) Dr Fiona Godlee remarked that paracetamol might be a better remedy than Tamiflu. “What I do know is that paracetamol is cheap and easy and has known side effects,” she says. “Whereas Tamiflu is relatively expensive and has an unknown safety and effectiveness profile.”

The crucial point that emerges from the report is that this lack of independent information about the drugs that are prescribed to us in increasing numbers is not confined to a few scandalous cases such a Tamiflu but may well be the norm. This is what Dr Godlee told the committee:

Drugs no longer effective but harmful

“Again and again we have evidence of unpublished results that, when combined with published results make the drugs look not only no longer effective but harmful.” These are drugs on which the NHS spends around 10 billion pounds a year. Quite apart from risks to health it seems very likely that this evidence gap involves a stupendous waste of money.

It’s a problem that’s been known about for nearly 30 years and yet has largely been ignored by doctors, health professionals and, most alarmingly, by the regulator. As one puzzled committee member asked: “What I don’t understand is why the regulatory bodies can’t say: “We are not going to authorise your drug to have NHS money spent on it unless we have 100% of all the trials?” The answer was that the regulator is only required to decide whether a drug is better than nothing (a placebo). There is no legal requirement for the information gathered about a drug to be made public.

This could be about to change due to a rather obscure series of court battles that are going on in the EU about the right of independent researchers to see the results of trials vs. the rights of the companies to keep them hidden. One of the serious arguments the companies have been using in defence of the status quo is that revealing information about the side effects of a drug could have a negative effect on their profits. Astonishing!

Regulatory and cultural failure

The Accounts Committee described the right of companies to conceal data as a “long standing regulatory and cultural failure”; campaigners for pharmaceutical transparency in the EU have also been making it clear that the current situation has to change. Without for a moment underestimating the resources, influence and dedication to the bottom line of the drug companies, it does seem likely that they are going to have to be a lot more open.

The results could be remarkable. What if it turns out, as Dr Godlee suggests, that many/most of the drugs currently in use turn out to be less effective and more dangerous than officially claimed? Could there be a huge cull of the prescription cabinet? Might there be a flood of court cases as it was revealed that drugs regularly described as “well tolerated” had actually been long known to do horrible things to your kidneys?

And in the wake of such revelations one sensible course of action would be to start taking prevention and a range of non-drug treatments that would almost be less risky, especially in combination. Interesting times.

Comments

In addition to providing all of the results I think each bottle should have 2 simple figures displayed on the bottle, one being the placebo figure and the other being the percentage ‘cured’ from the RCT. Each Doctor and very patient could then see quickly just how effective the drug had been. There could be a third figure too, how many months were side effects tested for.

Most people are unaware that many drugs only out perform placebo by 1% or 2% and this is deemed as scientifically proven. If doctor’s and patients new that a drug was only a couple of percent better than doing nothing then placebo then maybe they might choose changing diet instead or some other positive alternative.